Faulty Implantable Medical Device Causes Patient Fatality

Case Overview

This case involves the failure of a vagus nerve stimulator. The device was implanted in a child with severe epilepsy. Within two weeks, the child experienced several episodes with the device during which she was shocked by the device. Because of the episodes, the device was turned off, and the child soon became unstable and died. A biomedical engineering expert with experience designing implantable medical devices was sought to assess the device for a manufacturing defect.

Questions to the Medical Device expert and their responses

Have you worked in a design or engineering capacity relating to implantable medical devices?

I have a keen understanding of the interaction between medical devices and the human body. Understanding the potentially dangerous side effects of these devices that are capable of producing electrical and electromechanical stimulation and the important balance of therapeutic effects has been part of my career for almost 20 years. I have Ph.D. and MD degrees in medicine, undergraduate and master’s degrees in electrical and biomedical engineering respectively. With my background in electrical and computer engineering and both industrial and academic experience with design of implantable medical devices, I believe I have a strong background to review this case. In my current profession, I educate students in the electronics of implantable devices, such as pacemakers, muscle stimulators, etc. While in industry, I worked on a number of proprietary projects that gave me significant experience using electrical engineering approaches in device design, implantable devices, and non-implantable device.

Have you served as an expert involving a medical device failure?

Several models of the device in question underwent Class 2 Device Recalls due to delays in sensing during the use of the “verify heartbeat detection” feature. This recall was determined to be a Class 2 recall although the heartbeat detection controls the auto stimulation.

About the expert

This expert has over 20 years of experience in the field of biomedical engineering. He earned his BS from the Engineering College of Aarhus in Denmark and his MS in biomedical engineering from the Georgia Institute of Technology. He returned to Denmark to obtain his PhD in medicine and his MD from the University of Aarhus. Today, he is active in his field as a member of several professional societies, such as the Institute of Electrical and Electronics Engineers, and is the holder of 9 patents. He is also a reviewer for numerous journals, has lectured both nationally and internationally, and has been published in journals, books, and magazines. This expert previously served as a professor and as the director of biomedical research for the Scandinavian School of Cardiovascular Technology, as well as a research faculty member in biomedical engineering for the Georgia Institute of Technology. Most recently, he served as chief technology officer for Vivas LLC, a medical technology company. Currently, he serves as an associate professor of biomedical engineering and as an associate professor of cardiothoracic surgery at a university in Arkansas.

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Specialties:

Medical Device

Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.

Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.

Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.